Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

Centre Hospitalier Universitaire de Tivoli

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet; Drug: Sufentanil Sublingual Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04448457

P2017/348

Details and patient eligibility

About

The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehabilitation program.

SSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization.

SSTS will be randomly compared to nurse-driven oral Oxycodone.

Full description

Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.

After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (age ≥ 18 years)
• Scheduled for unilateral total knee arthroplasty under spinal anesthesia
• American Society of Anesthesiologists (ASA) class 1-3

Exclusion criteria

• Contraindication to medication used in our multimodal analgesia protocol (solumedrol, celecoxib, acetaminophen, ropivacaine)
• Allergy to study medications
• History of addiction or preoperative chronic use of opioids
• Unicompartmental or revision knee replacement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

SSTS group

Experimental group

Description:

Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively

Treatment:

Drug: Sufentanil Sublingual Tablet

Oxycodone group

Active Comparator group

Description:

Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively

Treatment:

Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet